dijous, 30 d’abril del 2015

US FDA identifies more than 20 PMA devices eligible for reclassification to Class II

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.

Emergo Group

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration's Center for Devices and Radiological Health (CDRH) has identified 21 medical device product codes as candidates for reclassification from Class III to Class II as part of a broad review of pre- and post-market data collection processes.

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